Adalat 5 Mg Soft Capsules
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Package leaflet - information for the user
0 Adalat 5 mg
Soft capsules Nifedipine
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have more questions, ask your doctor or pharmacist.
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
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In this leaflet | |
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1 |
What Adalat capsules are |
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2 |
Before you take Adalat capsules |
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3 |
How to take Adalat capsules |
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4 |
Possible side effects |
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5 |
How to store Adalat capsules |
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6 |
Further information |
What Adalat capsules are
Adalat capsules contain nifedipine, which belongs to a group of medicines called calcium antagonists.
Adalat capsules are used to treat high blood pressure, angina (chest pain) or a condition called Raynaud’s phenomenon which causes discolouration (often whitening) of the fingers and toes.
For high blood pressure: Adalat capsules work by relaxing and expanding the blood vessels. This makes the blood flow more easily and lowers blood pressure. Lower blood pressure reduces the strain on your heart.
For angina: Adalat capsules work by relaxing and expanding the arteries supplying the heart. This allows more blood and oxygen to reach the heart and decreases the strain on it. Your angina attacks will be less severe and less frequent if there is less strain on the heart.
Adalat capsules can increase the risk of serious heart problems in patients with high blood pressure or angina. Because of this, Adalat capsules are only used in these patients if no other treatments are appropriate.
For Raynaud's phenomenon: Adalat capsules work by relaxing and expanding the blood vessels in the fingers and toes. This helps ensure a good blood supply.
2 Before you take Adalat capsules
Do not take Adalat capsules:
• If you have had a heart attack within the last month.
• If you get a sudden angina attack. Adalat capsules will not help relieve symptoms of angina quickly.
• If you have unstable angina.
• If you are allergic to the active ingredient (nifedipine), to any other similar medicines (known as dihydropyridines) or to any of the other ingredients. The ingredients of Adalat capsules are listed in section 6.
• If you are taking rifampicin, an antibiotic.
• If you have been told that you have a narrowing of the aortic heart valve (stenosis).
• If you have ever had a collapse caused by a heart problem
(cardiogenic shock), during which you became breathless, pale and had a cold sweat and dry mouth.
• If your blood pressure continues to rise despite treatment (malignant hypertension).
Tell your doctor and do not take Adalat capsules if any of these apply to you.
Your doctor will take special care:
• If you have low blood pressure. Your blood pressure may be decreased further by this treatment.
• If you have a heart condition where your heart cannot cope with increased strain (poor cardiac reserve).
• If you are pregnant.
• If you are breastfeeding.
• If you are a diabetic. The treatment for your diabetes may need to be adjusted. If you have any questions about this, ask your doctor.
• If you are on kidney dialysis. If you have a very high blood pressure and a low blood volume, you might experience a sudden drop in blood pressure when you take Adalat capsules.
• If your liver is not working properly. Your doctor may need to do some blood tests. You may also be given a lower dose of Adalat capsules.
Talk to your doctor before you take Adalat capsules if any of these apply to you.
Tell your doctor:
• If your chest pain (angina) gets worse (comes on more often or more severely) over a matter of hours or days. You may be advised not to take Adalat capsules.
• If you have chest pains after taking your first dose of Adalat capsules. Your doctor may wish to change your treatment.
• If you notice increased breathlessness.
• If you notice swelling of the ankles.
Tell your doctor before you take the next dose if any of these apply to you.
Also tell your doctor:
• If you are giving a urine sample. Adalat capsules may interfere with the results of certain urine tests.
• If you are a man who has been unable to father a child by in
vitro fertilisation. Drugs like Adalat capsules have been shown to impair sperm function.
Other medicines and Adalat capsules
Tell your doctor about any other medicines that you are taking, or took recently. This includes any products you bought without a prescription.
Some medicines may affect the way Adalat capsules work. Tell your doctor if you are taking:
• Other medicines to treat high blood pressure.
• Rifampicin (an antibiotic).
• Cimetidine (to treat stomach ulcers).
• Digoxin, diltiazem, quinidine or beta-blockers (to treat heart conditions).
• Quinupristin/dalfopristin (a combination antibiotic).
• Phenytoin, carbamazepine or valproic acid (to treat epilepsy).
• Cisapride (to treat reduced movements of the gullet and stomach).
• Magnesium sulphate injections during pregnancy (may cause a severe fall in blood pressure).
• Erythromycin (an antibiotic).
• Ketoconazole, itraconazole or fluconazole (anti-fungal medicines).
• Indinavir, nelfinavir, ritonavir, saquinavir or amprenavir (to treat HIV).
• Fluoxetine or nefazodone (to treat depression).
• Tacrolimus (to prevent the rejection of transplanted organs).
• Phenobarbital (usually used to treat insomnia or anxiety).
Food and drink with Adalat capsules
You can take Adalat capsules either with or without food.
Do not drink grapefruit juice or eat grapefruit while taking Adalat capsules.
Do not start taking Adalat capsules within 3 days of drinking grapefruit juice or eating grapefruit. Tell your doctor if you have had grapefruit or grapefruit juice in this time. Also, do not drink grapefruit juice or eat grapefruit whilst taking Adalat capsules. Grapefruit juice is known to increase the blood levels of the active ingredient, nifedipine. This effect can last for at least 3 days.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning a family, tell your doctor before taking Adalat capsules.
You may be able to use Adalat capsules, but only after special consideration and agreement by your doctor.
Do not take Adalat capsules if you are breastfeeding. If you need to take Adalat capsules while breastfeeding, tell your doctor before taking the tablets.
Driving and using machines
Adalat capsules may make you feel dizzy, faint, extremely tired or have visual disturbances. Do not drive or operate machinery if you are affected in this way.
This may be more likely when you first start treatment, if you change tablets, or if you have drunk alcohol.
3 How to take Adalat capsules
Take the capsules as prescribed by your doctor.
• The recommended starting dose is one 5 mg capsule every 8 hours. This allows your doctor to monitor how you are responding so that the best long-term dose can be identified.
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• The dose can be increased to a maximum of 20 mg every 8 hours. |
• anxiety or nervousness |
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• Lower doses may be prescribed for elderly patients or for patients |
• reddening of the skin |
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who have liver problems. |
• nose bleeds |
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• Swallow the capsules whole with a little water. |
• nasal congestion |
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• Continue to take the capsules for as long as your doctor has told |
• sensation of spinning or whirling motion (vertigo) |
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you to. |
• migraine |
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Do not take them with grapefruit juice. |
• dizziness |
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You can take Adalat capsules either with or without food. Use in children: Adalat capsules are not recommended for use in children and adolescents below 18 years of age, because there are only limited data on the safety and efficacy in this population. If you take too many capsules |
• trembling • increase in the need to pass water (urinate) • painful or difficult urination • inability to achieve or maintain an erection (impotence) • blurred vision • temporary increase in certain liver enzymes |
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^ Get medical help immediately. If possible, take your capsules or the box with you to show the doctor. |
Rare side effects |
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Taking too many capsules may cause your blood pressure to become too |
(These may affect up to 1 in 1,000 people) |
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low and your heartbeats to speed up or slow down. It may also lead to |
• pins and needles |
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an increase in your blood sugar level or an increase in the acidity of your |
• inflammation of the gums, tender or swollen gums, bleeding gums |
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blood, swelling in the lungs, low blood oxygen levels and disturbances in consciousness, possibly leading to unconsciousness. |
Other side effects |
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If you forget to take the capsules |
(Frequency unknown) • vomiting |
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Take your normal dose immediately and continue taking your capsules as prescribed, waiting 8 hours before taking your next dose. Do not take a double dose to make up for the missed dose. |
• a reduction in the number of white blood cells (leucopenia) • a more severe decrease in a specific class of white blood cell (agranulocytosis) • increased blood sugar (hyperglycaemia) |
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4 Possible side effects |
• decreased skin sensitivity (hypoaesthesia) • drowsiness (somnolence) |
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Like all medicines, Adalat capsules can have side effects, although not |
• eye pain |
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everybody gets them. |
• chest pain (angina pectoris) • heartburn or indigestion (gastroesophageal sphincter insufficiency) |
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Serious side effects |
• yellowing of the whites of the eyes or skin (jaundice) |
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If you notice: • severe, sudden generalised allergic reaction including very rarely life- |
• sensitivity to light (photosensitivity allergic reaction) • small, raised areas of bleeding in the skin (palpable purpura) • joint pain |
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threatening shock (e.g. difficulty in breathing, drop of blood pressure, | |
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fast pulse) or swelling (including potentially life-threatening swelling of |
• muscle pain |
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the airway) |
All of these symptoms usually go away when treatment with Adalat |
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• other allergic reactions causing swelling under the skin (possibly |
capsules is stopped. |
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severe and including swelling of the larynx that may result in a life- | |
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threatening outcome) • fast heart beat (tachycardia) |
If you get side effects |
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• shortness of breath or difficulty breathing |
Tell your doctor if any side effect gets serious, or if you get |
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• mild to moderate allergic reactions • itching (possibly severe), a rash or hives |
any effects not listed in this leaflet. |
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Contact your doctor immediately and do not take the next dose as these may be the first signs of allergic reaction which may become severe. |
5 How to store Adalat capsules |
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Keep this medicine out of the reach and sight of children. | |
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If you develop: |
Store your medicine in its original container. Protect from strong light and |
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• a skin reaction or blistering/peeling of the skin and/or mucosal |
only remove the capsule from the blister strip when you are about to take |
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reactions (in the mouth/nose or at the penis/vagina) (Toxic Epidermal Necrolysis) |
it. Do not store above 30°C. |
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Contact your doctor immediately before you continue |
Do not use after the expiry date which is marked on both the outer carton |
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treatment as these may be signs of a severe reaction. |
and on each blister strip of capsules. |
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Less serious side effects |
Do not dispose of medicines in household rubbish. Any unused Adalat capsules should be returned to a pharmacist (chemist) who will dispose of |
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Apart from the side effects listed above, these are the other side effects of Adalat capsules, starting with the more common ones: |
them properly. This helps the environment. |
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Common side effects (These may affect up to 1 in 10 people) |
6 Further information What Adalat capsules contain |
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• headache | |
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• flushing |
Adalat capsules contain the active ingredient, nifedipine. |
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• general feeling of being unwell |
Adalat capsules also contain glycerol, purified water, saccharin sodium, |
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• constipation |
peppermint oil and macrogol 400. |
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• swelling, particularly of the ankles and legs |
The capsule shell contains gelatine, glycerol, titanium dioxide (E171) and |
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Uncommon side effects |
yellow orange S (E110). |
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(These may affect up to 1 in 100 people) |
What’s in the pack |
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• stomach pain (abdominal pain) • unspecific pain • chills • low blood pressure when standing up (symptoms include fainting, |
Each oval, soft gelatine capsule is filled with a viscous yellow liquid containing 5 mg of nifedipine. |
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Each pack contains 90 capsules. | |
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dizziness, light headedness, occasional palpitations, blurred vision |
Marketing authorisation holder: Bayer plc, Bayer House, Strawberry |
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and sometimes confusion) |
Hill, Newbury, Berkshire RG14 1JA |
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• fainting |
Manufacturer: Bayer Pharma AG, Leverkusen, Germany or Bayer |
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• irregular heartbeat (palpitations) |
HealthCare Manufacturing S.r.l. Garbagnate, Italy |
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• dry mouth |
This leaflet was last revised: November 2013 |
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• indigestion or upset stomach • wind (flatulence) • feeling sick (nausea) • muscle cramps • joint swelling |
Product licence number: PL 00010/0079 |
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• sleep disorders |
Bayer |
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PMR 81941130 (O8/01/MU-0201312083) Pantone: Schwarz, Orange 021 200x315-20027